Hey @tmcm

This would be a review specific question. There are examples where this could be done (e.g. unbranded patient support program) and examples where this could not (e.g. brand specific support programs which directly/indirectly allude to therapeutic use (e.g. require selection of patient characteristics which could identify the therapeutic use and suggest off-label use for other products in the program which do not possess the same indication; linking therapeutic use to products which a patient has not been prescribed also contravenes DTCA regulations [Section C.01.044 of the Food and Drugs Act and Regulations]). It would be best to submit for an opinion or full review.

Good morning @tmcm

If the pack shot does not contain copy/visuals which would render the piece reviewable, it may be exempt. Some examples of copy on the pack shot which could render the piece reviewable would be showing a device, drug classification, stating “oral”, dosing, or administration instructions.

Hello @tmcm

It is not that the website described is exempt from requiring a gate, it is that the controlled distribution of a de-indexed URL would be considered an acceptable gating mechanism.

Hi @tmcm

The use of a headline in a DTC campaign does not, in and of itself, prohibit its use in an HCP ad. The regulations for DTC advertising and HCP advertising vary and may impact the acceptability of copy depending on the context and audience. For clarity and completeness, we suggest being transparent about the use in the DTC campaign when submitting the HCP campaign for review.

Hello @tmcm

If the video is a looping video that is clearly designed as one piece for the copromotion of the three brands, it could be considered as one file.

Hey @keoca

You are correct that the non-selective addition of tabs for each heading throughout the product monograph, would not require submission to PAAB. The addition of branding colours to those tabs, in the manner described in your question, would not cause the document to require PAAB review. Any further modification may require the submission.

We recommend naming the document a Promotional/Clinical Monograph as it would appear from your description that the control number should be removed.

Modification limited to the addition of non-selective tabs, would not prompt the inclusion of fair balance. Note that changing the cover (beyond the control number removal) such as adding branding colours, elements, logos, would prompt review.

Good morning @keoca

The inclusion of the brand logo and PM, as well as a corporate message, is likely subject to review (would not meet exemption per code section 1.5E).

Good Morning @tmcm

Market research can be used to support non-therapeutic, non-comparative claims about a patient support program. The last paragraph of Tips on Claims Relating to Patient Assistance Program provides guidance relevant to this question.

Happy Friday @georgian21

PAAB Code section 5.1 states “The compared drugs/products have an authorized indication for use in common, and the comparison is related to that use; or, in addition to the common indication for use, a second authorized indication is claimed as an added benefit of the advertised drug”. As such, this type of comparison would not be acceptable.

Hello @skw

The fact that a website is created and controlled by a drug manufacturer’s parent company, outside of Canada, does not in and of itself render it exempt from Canadian drug advertising regulations (and the PAAB code). Even if the website URL is provided in a reactive manner, that website is likely subject to the regulations since the information that is available on the site far exceeds the question that prompted the URL to be shared.

The proposed activity could be considered exempt from the PAAB Code, PAAB Preclearance, and Canadian regulations if the mechanisms outlined in Q&A 176 were implemented. These mechanisms are provided to ensure the information provided is in response to the specific question asked. If all guiding principles from Q&A 176 are followed, this could be considered.

The PAAB can provide guidance on setting up a platform such as this, in the context of an opinion file.

As a reminder, one key aspect of the mechanism outlined, is “restricted access”. Canadians who are not HCPs must not have access to the site.

Hey @georgian21

The APS category helps us to track the types of tools being submitted and reviewed. They also provide context on if they are to be rep-directed or self-directed. This can have implications for the flow of the piece. In theory, an approved slide deck can be shared after the presentation, with the assumption that if there are speaker notes, they have been reviewed and approved as part of the piece. You should also consider how you disseminate the presentation, with additional guidance in the “Dissemination” section of the PAAB Clarification regarding digitization of APS Helping healthcare product manufacturers plan for the evolving COVID-19 operational context document.

If the presentation is to be recorded and distributed, this recording would require a separate review prior to being distributed. See paab.ca/myths (5) for further elaboration

Hello @tmcd

As per the document Tips on Claims Relating to Patient Assistance Programs,:
“Observational data on retention could be considered if the program has a valid and reliable mechanism to monitor when prescriptions are filled. Sufficient information about the program must be provided to enable PAAB to make this assessment. The APS claim/data from a manufacturer’s patient support programs should be non-comparative (as it relates to the manufacturer’s product), it should reflect past study findings (i.e. formatted in the past-tense), and it should be structured so as to limit the findings to the support program. Study parameters such as the time period pertaining to the claim/data could be relegated to a footnote. Note that retention data will be required to be updated every 6 months as changes in the market place can impact retention.”

Good Morning @donna
The proposed change did not go forward. Although these were intended as the beginning of an incremental process of change, following consultation it became clear that the industry felt that the guidance did not go far enough. We are therefore awaiting preliminary output from the ongoing Health Canada and CADTH collaboration on decision-grade RWE. An expert stakeholder committee will work through that output to determine which elements are applicable to drug advertising.

As a courtesy, the document Guidance on Observational Studies continues to inform on acceptable uses of observational studies in drug advertising.

Hey @Helen

Section 6.6 was revised and repositioned to 1.5. Alternatively, this may have been a typo in the response letter. Please follow up with your reviewer if section 1.5 does not address the issue. With regards to archived versions of the Code, per PAAB Q&A 717, the PAAB website only contains the most recent version of the code so as to clearly promote current best practices.

Hey @AnetteCPC

This would not be acceptable as the cookies would be placed on the computer, but they would not be able verify who is using that computer. If an HCP was to sign into a verified site on a shared computer, sign out and leave that computer, the next user would be exposed to advertising without verification that they are an HCP. This would contravene consumer regulations.